Postoperative pain is a significant concern in orthopaedic trauma patients, adversely affecting early mobilization, rehabilitation, and functional recovery. Adequate analgesia is essential to improve patient outcomes and reduce postoperative complications, including thromboembolism, pulmonary infections, and chronic pain syndromes. [1]. pain perception is a complex neurophysiological process involving transduction, transmission, modulation, and perception. Surgical tissue injury activates peripheral nociceptors, generating impulses that are transmitted via A-delta and C fibers to the dorsal horn of the spinal cord and subsequently through the spinothalamic tract to higher cortical centers, where pain is perceived[2]. Inflammatory mediators such as prostaglandins, bradykinin, histamine, and cytokines contribute significantly to nociceptor sensitization and pain signal amplification, leading to peripheral and central sensitization[3]. Studies indicate that more than 70% of patients experience moderate to severe postoperative pain within the first 48 hours, with orthopaedic patients reporting among the highest pain intensities [4]. Inadequate pain management raises the likelihood of chronic post-surgical pain (CPSP), which can last for months or years, in addition to increasing physiological stress and delaying wound healing. [5].

Multimodal analgesia using opioids, NSAIDs, paracetamol, and adjuvant agents is widely recommended for postoperative pain management. NSAIDs are particularly beneficial in orthopaedic patients due to their effective analgesic and anti-inflammatory actions with fewer opioid-related adverse effects. [6].

Both diclofenac and ketorolac are NSAIDs widely used in orthopaedic postoperative settings. They act primarily by inhibiting cyclooxygenase (COX) enzymes, thereby reducing the synthesis of prostaglandins, which are key mediators of pain and inflammation [8]. Diclofenac is a non-selective COX inhibitor, with a slight preference for COX-2, offering effective pain relief and inflammation control. It also stabilizes lysosomal membranes and reduces leukocyte migration [9]. Ketorolac is a potent non-selective COX inhibitor with analgesic efficacy comparable to opioids. It exerts a stronger central and peripheral analgesic effect than most NSAIDs, making it suitable for short-term use in acute postoperative pain [10]. However, due to its potential for gastrointestinal and renal side effects, its duration of use is typically limited to 5 days [11]. This study aims to evaluate and compare the analgesic efficacy of ketorolac and diclofenac using the Visual Analogue Scale (VAS) in the immediate postoperative period, to aid in optimizing pain management protocols.

Study Setting and Ethical Approval This prospective, randomized study was conducted in the Department of Orthopedics at Raja Rajeshwari Institute Of Medical Sciences. Hyderabad, Telangana after obtaining approval from the Institutional Ethics Committee. Written informed consent was obtained from all participants prior to enrollment. Study Population and Sample Size A total of 332 postoperative orthopaedic patients were included in the study and randomly assigned into two equal groups. Inclusion Criteria • Patients aged >50 years • Patients of either sex • Patients willing to provide written informed consent • Patients undergoing recent orthopaedic surgery with postoperative pain Exclusion Criteria • Patients aged <50 years • Pregnant or lactating women • Patients unwilling to provide informed consent • Patients with previous surgery receiving ongoing analgesic therapy • Patients with a history of alcohol consumption, smoking, or other substance abuse Study Groups Participants were randomly allocated into the following groups: • Group A (n = 166): Diclofenac 75 mg intravenously every 12 hours for 48 hours • Group B (n = 166): Ketorolac 30 mg intravenously every 8 hours for 48 hours Study Procedure Baseline demographic and clinical characteristics, including age, sex, comorbidities, educational status, socioeconomic status, occupation, area of residence, and common postoperative symptoms, were recorded for all patients. Postoperative pain intensity was evaluated using the Visual Analog Scale (VAS; 0–10 cm) and Numerical Rating Scale (NRS; 0–10). Pain severity was categorized as mild (0–3), moderate (4–6), and severe (7–10). Baseline pain assessment was performed immediately after surgery before administration of study medications. Following treatment allocation, patients received the assigned analgesic regimen. Pain assessments were subsequently performed at 2, 6, 12, 24, and 48 hours post-treatment to evaluate analgesic efficacy.

Table 2: VAS Pain Score difference in between group A and B.

Table 1: Sociodemographical status of postoperative pain in orthopedic trauma in group A and B.

 Table 3: NRS Pain Score difference in between group A and B.

Table 4: Estimated Distribution of Pain Score Categories (VAS/NRS)

The two groups (Group A and Group B, each with 161 patients) had similar clinical and demographic features across a number of factors, indicating balanced baseline characteristics.

The groups' age distribution was comparable. 21.1% (34 patients) in Group A and 19.3% (31 patients) in Group B were between the ages of 18 and 30. 28.0% (45 patients) in Group A and 29.8% (48 patients) in Group B fell into the 31–45 age group. Patients between the ages of 46 and 60 made up 26.1% (42 patients) in Group A and 24.2% (39 patients) in Group B, whereas patients beyond 60 made up 24.8% (40 patients) and 26.7% (43 patients), respectively. Age-related confounding effects are reduced by this uniform distribution across age groups. George NE and associates (2020)[12] found that patients undergoing total hip and knee replacement had an average age of 65.7 years. Age-matched groups were given either ketorolac or diclofenac. Rajkiran and associates (2020) [13] compared the effects of diclofenac and paracetamol on postoperative pain in patients with supratentorial craniotomies, whose mean age was 45.3 years. The effectiveness of intravenous diclofenac and ketorolac in postoperative pain management was evaluated in a comprehensive review by O'Neill BJ, et al. (2019) [14], which included trials with a range of age groups

In terms of gender, men made up the majority in both groups—60.2% (97 patients) in Group A and 63.4% (102 patients) in Group B—while women made up 39.8% (64 patients) and 36.6% (59 patients), respectively. There was no discernible difference in the gender distribution between the groups. In George NE et al.'s study, [12] To ensure comparability, the diclofenac and ketorolac groups' gender distribution was balanced. According to Rajkiran et al. [13], 60% of the study population was male and 40% was female in both treatment groups. Although the review by Gan TJ et al. [15] included papers with different gender distributions, it generally maintained a balanced representation across treatment arms.

Comorbidity profiles were also similar. More than half of the patients in both groups had no comorbidities—54.7% (88 patients) in Group A and 56.5% (91 patients) in Group B. Hypertension was present in 21.1% (34 patients) and 19.3% (31 patients), and diabetes mellitus in 12.4% (20 patients) and 13.7% (22 patients) of Group A and B respectively. A small proportion had both hypertension and diabetes (6.2% in Group A and 5.6% in Group B). Other comorbidities were reported in 5.6% (9 patients) and 5.0% (8 patients). George NE et al. excluded patients with significant comorbidities, focusing on ASA I and II patients to minimize confounding factors. Rajkiran et al. included patients without major systemic diseases, ensuring a homogeneous study population.  Gan TJ et al.'s analysis considered studies that often-excluded patients with severe comorbidities, aiming for uniformity in health status among participants.

The education status showed no major differences between groups. Illiteracy was noted in 18.6% (30 patients) of Group A and 17.4% (28 patients) of Group B. The majority had some level of formal education, with 25.5% (41 patients) in Group A and 24.2% (39 patients) in Group B having primary education, 31.1% (50 patients) and 32.9% (53 patients) having secondary education, and around a quarter attaining higher secondary or above (24.8% in Group A and 25.5% in Group B).

Socioeconomic status categories also aligned closely. Upper socioeconomic status was rare (3.1% in Group A, 3.7% in Group B). The majority fell into the lower-middle and upper-lower classes, with 32.3% (52 patients) and 31.1% (50 patients) in Group A, and 31.1% (50 patients) and 32.3% (52 patients) in Group B respectively. Lower status was noted in 15.5% and 14.3%.

Regarding occupation, labourers /workers formed the largest subgroup in both groups (39.8% in Group A, 38.5% in Group B). Unemployed individuals represented 17.4% and 18.6%, office/clerical workers 15.5% and 14.3%, business/self-employed 12.4% and 13.7%, and others about 14.9% in both groups.

The area of living was predominantly urban in both groups: 60.2% (97 patients) in Group A and 58.4% (94 patients) in Group B, with the remainder living in rural areas.

Lastly, postoperative symptoms were frequent but similar between groups. Pain was the most common symptom, reported by 74.5% (120 patients) in Group A and 78.3% (126 patients) in Group B. Swelling affected approximately 40% in both groups. Fever was reported in about 20% of patients, nausea/vomiting in 15–17%, and wound discharge in under 10%. A small proportion reported no significant symptoms (11.2% in Group A and 8.7% in Group B).

This study compared the postoperative analgesic effectiveness of Diclofenac (Group A) and Ketorolac (Group B) using both Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) scores over a 48-hour period.

Baseline VAS scores were comparable between the Diclofenac and Ketorolac groups (7.6 ± 1.2 vs. 7.5 ± 1.1; p = 0.692). However, Diclofenac showed significantly greater pain reduction from 2 hours onwards, with consistently lower VAS scores at 2, 6, 12, 24, and 48 hours compared to Ketorolac (p < 0.05 at all intervals), indicating sustained superior analgesic efficacy.

A comparable trend was observed in NRS scores, with no significant difference at baseline between the Diclofenac and Ketorolac groups (7.8 ± 1.0 vs. 7.7 ± 1.1; p = 0.738). However, Diclofenac produced significantly greater reductions in NRS scores from 2 hours onward, demonstrating superior analgesic efficacy at 2, 6, 12, 24, and 48 hours postoperatively (p < 0.05 at all intervals).

Analysis of pain severity categories revealed that both groups predominantly presented with moderate to severe pain at baseline. Following treatment, patients receiving Diclofenac exhibited a more rapid transition toward mild and moderate pain categories, with fewer patients reporting severe pain compared to the Ketorolac group during subsequent assessments, further supporting the enhanced analgesic effectiveness of Diclofenac.

While moderate and severe pain declined at six hours, the number of patients experiencing mild pain rose to eight in the Diclofenac group and four in the Ketorolac group. Only six individuals in the Ketorolac group had minor pain after 12 hours, compared to sixteen in the Diclofenac group. Ten participants in the Ketorolac group and 22 patients in the Diclofenac group experienced minor pain at 24 hours. In contrast to the Ketorolac group, which had only 14 patients with light pain, 10 with moderate pain, and 6 with severe pain at 48 hours, the Diclofenac group had 26 patients with mild pain and none with severe pain. These findings show that Diclofenac not only reduced pain more quickly than Ketorolac, but it also assisted a greater percentage of patients in moving to light pain categories more quickly. Diclofenac's greater and long-lasting analgesic impact in treating postoperative orthopedic pain over a 48-hour period is demonstrated by the statistically significant differences in both mean scores and severity distributions. According to George NE et al. (2020) [12], the frequencies of common postoperative complaints such nausea and vomiting were comparable in the diclofenac and ketorolac groups. The incidence of postoperative symptoms did not significantly differ between the diclofenac and paracetamol groups, according to Rajkiran et al. (2020) [13]. The review by McEvoy MD et al. (2020) [16] found that intravenous diclofenac and ketorolac had similar side effect profiles in several different studies.

The present study demonstrated that both Diclofenac and Ketorolac provided effective postoperative analgesia in orthopaedic trauma patients; however, Diclofenac exhibited superior and sustained pain control over the 48-hour postoperative period. Although baseline pain scores were comparable between the groups, patients receiving Diclofenac showed significantly lower VAS and NRS scores from 2 hours onward compared to those receiving Ketorolac. Furthermore, a greater proportion of patients in the Diclofenac group transitioned to mild pain categories by 48 hours, whereas moderate to severe pain persisted in a subset of patients receiving Ketorolac. These findings suggest that Diclofenac offers enhanced and prolonged analgesic efficacy in the postoperative management of orthopaedic trauma patients.

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